NCT03075215

Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry

Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,044 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others. A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)	The optimization during the standard of care visits in the first 12 months following implantation

Timeline

• Start date: 2017-04-14
• Primary completion: 2021-11-15
• Completion: 2021-11-15
• First posted: 2017-03-09
• Last updated: 2023-10-25
• Results posted: 2023-10-02

Locations

139 sites across 15 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Italy, Netherlands, Portugal, Slovakia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study